Aldagen and Texas Heart Institute to Begin Clinical Study of Stem Cell Therapy for Advanced Heart Failure Patients
FDA Clears Investigational New Drug to Begin Clinical Study
Durham, NC (February 21, 2006) Aldagen, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared a clinical study for physicians led by Dr. Emerson Perin and Dr. James Willerson of the Texas Heart Institute at St. Luke’s Episcopal Hospital in Houston, Texas, to conduct a clinical trial using Aldagen’s ALDESORT product to isolate a unique stem cell population for therapy for advanced heart failure patients. It will be the first clinical trial involving this unique cell population for therapy for heart failure patients in the United States.
“We are very excited about the FDA clearance to begin this work in the Texas Medical Center at the Texas Heart Institute and St. Luke’s. We believe these cells have the potential to find a very important place in the future treatment of patients with heart and vascular disease,” said Drs. Willerson and Perin. Dr. James Willerson is president-elect and medical director of the Texas Heart Institute at St. Luke’s and President of The University of Texas Health Sciences Center at Houston. Dr. Perin is director of New Cardiovascular Interventional Technology and director of the Stem Cell Center at the Texas Heart Institute at St. Luke’s.
Drs. Willerson and Perin have been conducting a clinical trial in the United States using unfractionated bone marrow cells. Using a special catheter which is threaded through the groin, the doctors use an innovative mapping technology to identify areas in the heart which have sustained mechanical and electrical damage. Using that same catheter, doctors have injected millions of these bone marrow cells directly into the muscle of the left ventricle along the periphery of the damaged area. The procedure, which is conducted in a few hours, has yielded promising results.
ALDESORT isolates a highly potent population of stem cells taken from the patient’s own bone marrow. These cells are more active in restoring blood flow to damaged tissue than unfractionated bone marrow in pre-clinical animal models. These stem cells have the potential to build new blood vessels (angiogenesis) in damaged hearts which could ultimately lead to improved functional improvement in advanced heart failure patients.
The first pilot phase of the study, which involves ten patients, is designed primarily to test for safety. In all, up to 60 patients will be enrolled in the study and randomized, with half of them receiving stem cells isolated by ALDESORT.
“We are delighted to be working with a leading institute like the Texas Heart Institute at St. Luke’s for our first cardiovascular stem cell therapy trial. We look forward to initiating the trial and determining whether the injection of ALDESORT isolated stem cells can improve the health of heart failure patients,” added Ed Field, President and CEO of Aldagen.
For more information, call the Texas Heart Institute's Heart Information Center at 1-800-292-2221, visit online at www.texasheart.org/stemcell or e-mail directly to plea@heart.thi.tmc.edu.
About Aldagen, Inc.
Aldagen’s proprietary products identify and isolate unique populations of adult stem cells with the potential to revolutionize treatments of cardiovascular disease and degenerative diseases. The Company is now testing these products in clinical trials. To learn more about Aldagen’s products for preparing optimal cell populations for adult stem cell therapy, the Company invites you to visit its website at www.aldagen.com.
About The Texas Heart Institute and St. Luke’s
World-renowned cardiovascular surgeon Denton A. Cooley, M.D., founded the Texas Heart Institute in 1962. The Texas Heart Institute is dedicated to reducing the devastating toll of cardiovascular disease through innovative programs in research, education and improved patient care. Together with the Institute’s clinical partner, St. Luke’s Episcopal Hospital, it has been ranked among the nation’s top 10 heart centers in an annual survey published by U.S.News & World Report for the past 15 years.
St. Luke’s Episcopal Health System comprises the flagship St. Luke’s Episcopal Hospital in the Texas Medical Center, founded in 1954 by the Episcopal Diocese of Texas; St. Luke’s Community Medical Center – The Woodlands, opened in 2003; St. Luke’s Episcopal Health Charities, a charity devoted to assessing and enhancing community health, especially among the underserved; and Kelsey-Seybold Management, LLP, overseeing 21 area clinic locations. St. Luke’s Episcopal Hospital is home to the Texas Heart Institute, founded in 1962 by Denton A. Cooley, M.D., and consistently ranked among the top 10 cardiology and heart surgery centers in the nation by U.S. News and World Report. Affiliated with several nursing schools and two medical schools, St. Luke’s serves as the primary adult teaching hospital for Baylor College of Medicine. St. Luke’s was the first hospital in Texas named a Magnet hospital for nursing excellence, and the Health System has been recognized by FORTUNE as among “100 Best Companies to Work For” (2002, 2004 and 2005) and by Houston Business Journal as a top employer in Houston for three consecutive years.
For more information, contact:
Ed Field, President and CEO
Aldagen, Inc.
919-484-2571
efield@aldagen.com
www.aldagen.com
Kathy Watson
Manager, Media Relations and Publications
Texas Heart Institute
832-355-6569
kwatson@heart.thi.tmc.edu
